BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).
Study Type
OBSERVATIONAL
Enrollment
750
Observation of real-life treatment with encorafenib and binimetinib
Observation of real-life treatment with encorafenib and binimetinib
11
Graz, Austria
RECRUITING13
Innsbruck, Austria
RECRUITING14
Klagenfurt, Austria
RECRUITING10
Linz, Austria
Progression-free survival
Progression-free survival rate
Time frame: At 12 months after start of treatment
Patient and disease profiles at start of treatment with encorafenib plus binimetinib
Demographic and disease characteristics
Time frame: Baseline
Type of treatments before and after encorafenib plus binimetinib
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Sequence of treatments before and after encorafenib plus binimetinib
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Characteristics of treatment with encorafenib plus binimetinib
Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Further progression-free survival parameters
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Time-to-progression
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Best observed tumor response
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Overall response rate
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Duration of response
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Disease control rate
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Duration of disease control
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
Overall survival
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Patient reported outcomes during treatment with encorafenib plus binimetinib - evaluated with EORTC QLQ C-30
EORTC QLQ C-30 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life C-30 questionnaires) to assess quality of life of cancer patients; comprises 30 items, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with WPAI
WPAI questionnaires (Work Productivity and Activity Impairment questionnaires). The following questions ask about the effect of patients melanoma on the ability to work and perform regular activities. 1. Are you currently employed (working for pay)? 2. During the past seven days, how many hours did you miss from work because of problems associated with your melanoma? 3. During the past seven days, how many hours did you miss from work because of any other reason? 4. During the past seven days, how many hours did you actually work? 5. During the past seven days, how much did your melanoma affect your productivity while you were working? 6. During the past seven days, how much did your melanoma affect your ability to do your regular daily activities, other than work at a job?
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with CTSQ
CTSQ questionnaires (Cancer Therapy Satisfaction Questionnaire) to assess patients' opinions and feelings concerning their cancer therapy and associated adverse events: 1. Questions to patients thoughts about cancer therapy (IV/pills). Scale: \[Always, Most of the time, Some-times, Rarely, Never\]; 2. Questions to patients satisfaction with the most recent cancer therapy (IV/pills): 1. Scale reg. benefit: \[Much better than my expectations Somewhat better than my expectations, Met my expectations, Somewhat worse than my expectations, Much worse than my expectations\]; 2. Scale reg. side effects: \[Much better than I expected, Somewhat better than I expected, Exactly as I expected, Somewhat worse than I expected, Much worse than I expected\]; 3. Scale reg. satisfaction: \[Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied\]; 4. Scale reg. choice of therapy: \[Yes, definitely, Probably Yes, I don't know, Probably not, Definitely not\]
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Physicians' satisfaction with regard the treatment with encorafenib plus binimetinib
Physicians' satisfaction questionnaires (measuring Physician's Satisfaction with regard to Effictiveness and Safety, as well as Physician's Overall Treatment Satisfaction) using the following scale construct: 1. Physician's Satisfaction with regard to Efficiency 2. Physician's Satisfaction with regard to Safety 3. Physician's Overall Treatment Satisfaction Scale: * very dissatisfied * dissatisfied * moderately satisfied * satisfied * very satisfied
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Safety and tolerability of treatment with encorafenib plus binimetinib - Adverse events and adverse reactions including time to onset and time to resolution
Number of patients with Adverse Events and maximum grade per patient, Adverse Drug Reactions, Adverse Drug Reactions grade 3/4, Serious Adverse Events, Serious Adverse Drug Reactions.
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Prognostic factors
Influence of prognostic factors on quality of life outcome parameters
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Prognostic factors
Influence of prognostic factors on effectiveness
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Prognostic factors
Influence of prognostic factors on safety
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Treatment duration
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Treatment dose intensity
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Number of treatment interruptions
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Duration of treatment interruptions
From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last)
Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
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3
Linz, Austria
RECRUITING12
Salzburg, Austria
RECRUITING22
Vienna, Austria
RECRUITING53
Vienna, Austria
RECRUITING23
Wiener Neustadt, Austria
RECRUITING45
Ahaus, Germany
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